Drugs@FDA: FDA-Approved Drugs
Company: PAI HOLDINGS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 120MG/5ML;12MG/5ML | SOLUTION;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
04/26/1996 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/31/2024 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
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02/08/2024 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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02/08/2024 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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03/04/2021 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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10/07/2019 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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09/20/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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09/18/2018 | SUPPL-13 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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01/29/2018 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
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08/29/2017 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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08/29/2017 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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12/16/2016 | SUPPL-9 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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12/16/2016 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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10/22/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
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05/16/2013 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
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11/12/2014 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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06/23/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
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09/12/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |